Prehabilitation Program for Patients Awaiting Elective Heart Surgery at Increased Risk of Postoperative Complications: Feasibility and Potential Clinical Outcomes

NCT07144722 | Not Yet Recruiting

• 1 other identifier: 2025-3527
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn if an exercise-based prehabilitation program can help people who are waiting for heart surgery and are at higher risk of complications recover better. The main questions it aims to answer are: Can a home-based prehabilitation program prescribed by a physiotherapist be done safely and realistically before heart surgery? Participants will: Take part in a personalized exercise program for a 8 to 16 weeks before surgery Do breathing muscle training at home Meet with a physiotherapist once a week, either in person or by video call Be assessed before and after the program Researchers will compare the postoperative results with those of patients who received usual care only.

Conditions

Cardiac Surgery; Prehabilitation; Postoperative Complications

Keywords

exercise-based prehabilitation; pulmonary postoperative complications; teleprehabilitation; elective surgery; cardiac procedures

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate (%)

  Proportion of eligible candidates who enroll in the study. Recruitment rate will be calculated as the number of participants enrolled divided by the number of eligible candidates, multiplied by 100.

  From enrollment to the end of treatment at maximum 16 weeks

• Adherence Rate (%)

  Proportion of participants who complete at least 70% of prescribed exercise sessions. Calculated as the number of participants meeting this threshold divided by the total number enrolled, multiplied by 100.

  From enrollment to the end of treatment at maximum 16 weeks

• Program Safety - number of participants experiencing exercise-related adverse events

  Count of participants experiencing one or more adverse events during the program, including angina, arrhythmias, myocardial infarction, acute heart failure, or sudden cardiac death of cardiac origin.

  From enrollment to the end of treatment at maximum 16 weeks

• Participant Satisfaction - likelihood to recommend

  Among participants who complete the program, the self-reported likelihood of recommending the program to others, measured on a numeric rating scale from 0 ("not at all likely") to 10 ("extremely likely").

  From enrollment to the end of treatment at maximum 16 weeks

• Participant Satisfaction - likelihood to repeat

  Among participants who complete the program, the self-reported likelihood of participating in the program again, measured on a numeric rating scale from 0 ("not at all likely") to 10 ("extremely likely").

  From enrollment to the end of treatment at maximum 16 weeks

Secondary Outcomes (11)

• Maximal Inspiratory Pressure (cmH2O)

  From enrollment to the end of treatment at maximum 16 weeks

• Diaphragm Thickening Fraction (%)

  From enrollment to the end of treatment at maximum 16 weeks

• Grip Strength (kg)

  From enrollment to the end of treatment at maximum 16 weeks

• 5-repetition-sit-to-stand Test - Lower Limb Strength (seconds)

  From enrollment to the end of treatment at maximum 16 weeks

• 5-meter Gait Speed (seconds)

  From enrollment to the end of treatment at maximum 16 weeks

Other Outcomes (5)

• Postoperative pulmonary complication - Exploratory Outcome Measures - Comparison of Postoperative Recovery Indicators Between Study Participants and Historical Controls

  The month following the completion of primary and secondary data collection

• Postoperative Recovery - Exploratory Outcome Measures - Comparison of Postoperative Recovery - Duration of Mechanical Ventilation - Between Study Participants and Historical Controls

  The month following the completion of primary and secondary data collection

• Postoperative Recovery - Exploratory Outcome Measures - Comparison of Postoperative Recovery - Recovery of mobility (first mobilization out of the bed) - Between Study Participants and Historical Controls

  The month following the completion of primary and secondary data collection

Study Arms (1)

Prehab group

EXPERIMENTAL

Supervised by a physiotherapist, the program includes an initial functional assessment, individualized training (breathing exercises, aerobic and strengthening exercises), and weekly follow-up via videoconference or phone.

Other: Exercise

Interventions

Exercise OTHER

What distinguishes this intervention from others is its hybrid delivery model, combining virtual more than in-person sessions to increase accessibility and adherence. Additionally, it incorporates specific inspiratory muscle training, which is often overlooked in standard prehabilitation programs, and emphasizes a personalized progression based on each participant's functional capacity and feedback. This tailored approach aims to optimize physical readiness before surgery while minimizing patient burden and travel requirements.

Also known as: Inspiratory muscle training

Prehab group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A high risk of perioperative and postoperative complications. This risk is determined based on the predictive thresholds for postoperative complications.
• A waiting period of at least 8 weeks.
• Access to a smartphone, tablet, or computer for videoconference visits.

You may not qualify if:

• Unstable angina, malignant arrhythmias, active endocarditis/myocarditis, myocardial infarction within the last 2 weeks, left main coronary artery disease ≥ 50% on coronary angiography, severe aortic stenosis, severe mitral insufficiency, and decompensated heart failure.
• Any other acute condition affecting vital signs or causing significant symptoms.
• Physical or cognitive impairment limiting the ability to participate in the program.

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Montreal Heart Institut

Montreal, Quebec, H1T1C8, Canada

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Silvanna Cardoso

CONTACT

15143763330; silvanna.cardoso@icm-mhi.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthésiologiste

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 27, 2025
• Study Start: September 15, 2025
• Primary Completion: April 15, 2026
• Study Completion: June 15, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)